MAUDE Adverse Event Report: DEPUY MITEK LLC US UNKNOWN RIGIDFIX CROSS PIN; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number UNK RIGIDFIX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Loss of Range of Motion (2032)

Event Type  Injury  

Manufacturer Narrative

Brand name, common device name, procode, mfr, lot #, part #, udi #, 510k: this report is for an unknown rigidfix cross pin.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Concomitant medical products: unk - guides/sleeves - rigidfix, unknown bio-intrafix.(b)(4).Device evaluated by mfr, manufacture date: without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.

Event Description

This report is being filed after the review of the following journal article: piotr wójcicki et al ,2005, "anterior cruciate ligament reconstruction with st grafts and rigidfix and intrafix fixation devices" polish orthopedics and traumatology, 70 (1), page no:9-12, poland.The study emphasizes on the clinical outcomes of anterior cruciate ligament reconstruction when performed with st grafts and rigidfix and intrafix fixation devices.The patients evaluated on course of this study: between january 2000 and december 2001, 563 patients(18-55 years ) (mean age-30 years old) with trauma induced knee dysfunction were treated at loro.Amongst this group 79 patient were diagnosed with partial and 43 with total anterior cruciate ligament injury.17 acl reconstructions were performed, utilizing semitendinosus muscle tendons and gracilis muscle tendons.The inclusion criteria were: occurence of trauma due to participation in recreational sports , accidents at work,5 patients who underwent partial meniscectomy, three patients with cartilage repair.The exclusion criteria were: secondary degenerative irregularities, extremely limited mobility, extension deficits, lack of physical fitness associated with age.The article describes the following procedure: anterior cruciate ligament reconstruction was performed by harvesting flexor tendons: semitendinosus and gracilis muscle.All the 17 patients underwent a follow up on average 10 months after surgery.The devices involved were: a tibial guide device was utilized to introduce a k-wire, in arthroscopic preparation of the joint.Absorbable cross pins were introduced via cannulas inserted into the tunnels whilst keeping the graft under tension.In order to finalize the surgical procedure an intrafix sheath and screw are used for tibial fixation.Complications mentioned in the article were: continued discharge from the wound and limited knee flexion was observed in 3 cases postoperatively.From the review of this article it is concluded that mitek devices mentioned cannot be disassociated with any complication noted in the article.

• Brand Name: UNKNOWN RIGIDFIX CROSS PIN
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 8836510
• MDR Text Key: 152504422
• Report Number: 1221934-2019-57833
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK RIGIDFIX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/09/2019
• Initial Date FDA Received: 07/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention